Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
calculation (if not (Q)SAR)
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
accepted calculation method

Data source

Referenceopen allclose all

Reference Type:
secondary source
Title:
Unnamed
Year:
2017
Report Date:
2017
Reference Type:
secondary source
Title:
Unnamed
Year:
2016
Report Date:
2016
Reference Type:
publication
Title:
Unnamed
Year:
2003
Report Date:
2003
Reference Type:
secondary source
Title:
Unnamed
Year:
2015
Report Date:
2015

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other:
Principles of method if other than guideline:
Based on a weight of evidence approach, the acute toxicity oral of this UVCB substance can be estimated using adequate toxicity data of major constituents, greater than 1% in the mixture.
7 constituents were considered, representing 87% of the mixture. But 4 constituents have an available LD50 oral.These data are summarized in the table below.
The acute toxicity oral was estimated using the following additivity formula, as recommended in the Regulation (EC) No 1272/2008 (CLP) part 3.1.3.6.2.3.:
100-(∑ Ci unkown if > 10 %) / ETA mix = ∑ (Ci / ETAi)Where,Ci = concentration of component i (weight percentage); i = the individual ingredient from 1 to n ; n = the number of ingredients ; ATE i = Acute Toxicity Estimate of ingredient i.

Test material

Reference
Name:
Unnamed
Type:
Constituent

Results and discussion

Effect levels
Sex:
not specified
Dose descriptor:
approximate LD50
Effect level:
ca. 6 014 mg/kg bw
Based on:
other: calculation according to additivity formula of CLP regulation section 3.1.3.6.2.3.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The lavandin oil heavy fraction is not classified according to CLP criteria and GHS criteria.